Global Regulatory Affairs

Submissions in Middle East and North Africa

The rapid population increase in the Middle East and North Africa has led to a growing demand for medicines, making this region an attractive option for the marketing of pharmaceutical products. One such example is the Kingdom of Saudi Arabia, one of the most important in terms of projected growth potential.

With these future growth predictions, governments in the region are promoting health through reforms and standards with a view to regulating the sector.

MENA Regulatory Submissions – GCC Countries

The Gulf Cooperation Council (GCC) is focusing on developing regulations that would apply to the entire region, and which would be mandatory for the marketing of products in this market. Thus, if you wish to gain authorisation to market your products in any country in the GCC region, you must comply with the conditions and procedures set out in its guidelines.

Arriello can help you with the applications and with the introduction of the regulatory framework required by the Saudi Food and Drug Authority (SFDA), which would grant approval.

The applications apply to the type of medicines:

  • New drugs
  • Generics
  • Biologics
  • Radiopharmaceuticals
  • Herbal and Health products
  • Veterinary products
  • Renewals of MA
  • Variations type I and II

* Gulf Cooperation Countries: Kingdom of Bahrain, Kuwait, Sultanate of Oman, Qatar, Kingdom of Saudi Arabia (KSA), United Arab Emirates  

Other MENA countries covered

Algeria, Egypt, Iran, Iraq, Hashemite Kingdom of Jordan, Israel, Lebanon, Libya, Morocco, Syria, Tunisia and Yemen.

Sometimes considered part of MENA: Sudan and Turkey

Business Cases

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